Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR)

NCT06203977 | Recruiting Phase 1

• 1 other identifier: REPAIR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

Phase 1 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort. Open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.

Conditions

Chronic Kidney Diseases; Renal Failure

Keywords

Tolerance; Colchicine Resistance; Hematologic markers

Outcome Measures

Primary Outcomes (2)

• Dose tolerance

  Proportion of participants who permanently discontinue colchicine at either the 0.3 mg daily dose or 0.6 mg daily dose (to estimate the proportion who would discontinue the study drug at the 0.6 mg daily dose without titration).

  Up to 17 weeks

• Early discontinuations

  Proportion of participants who permanently discontinue colchicine at the 0.3 mg daily dose.

  Up to 17 weeks

Secondary Outcomes (3)

• Reason for drug discontinuation

  Up to 17 weeks

• Drug adherence

  Up to 17 weeks

• Major Side Effects

  Up to 17 weeks

Other Outcomes (1)

• Colchicine Concentration

  Up to 17 weeks

Study Arms (2)

REPAIR CKD cohort

ACTIVE COMPARATOR

Patients will receive open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.

Drug: Colchicine

REPAIR Dialysis cohort

ACTIVE COMPARATOR

Patients will receive open label colchicine 0.3 mg daily for 8 weeks followed, in patients who tolerated the 0.3 mg dose, by forced titration to 0.6 mg daily for 8 weeks.

Drug: Colchicine

Interventions

Colchicine DRUG

0.3mg and 0.6mg tablets

REPAIR CKD cohort; REPAIR Dialysis cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One of either:
• Estimated GFR using CKD-EPI 2021 equation of ≤30 ml/min/1.73m2 on at least two occasions separated by at least 2 months and do not yet require dialysis and are not expected by their treating nephrologist to require dialysis in the next 6 months (REPAIR CKD cohort), or 1.3 receiving chronic maintenance dialysis 2 or more times per week for the previous 90 days (REPAIR Dialysis cohort);
• Age ≥18 years
• Provide informed consent to participate.

You may not qualify if:

• Currently treated with and cannot withdraw colchicine due to medical necessity; or
• Known allergy/sensitivity to colchicine; or
• Prior self-reported intolerance to colchicine at a dose of 0.6 mg daily or lower; or
• Currently pregnant or planning to become pregnant or breastfeed during the study; or
• Of childbearing potential AND do not have a negative pregnancy test OR do not agree to use two forms of contraception for the duration of the study; or
• Anticipated living donor renal transplant within the next 6 months; or
• Using a strong inhibitor of p-glycoprotein or strong inhibitor of CYP3A4 in the last 14 days; or
• B12 deficiency not managed with intramuscular supplementation; or
• Uncontrolled chronic diarrhea; or
• Cirrhosis, or chronic active hepatitis; or
• Pre-existent neuromuscular disease or persistent serum CK level \> 3 times the upper limit of normal as measured within the past 60 days and determined to be non-transient through repeat testing; or
• Patient with any of the following within the past 60 days:
• white blood cell count \< 3.0 X 109/L; or
• platelet count \<110 X 109/L; or
• ALT or AST \> 3 times the upper limit of normal (ULN); or

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Hamilton Academic Health Sciences Organization: collaborator
• St. Joseph's Health Care London: collaborator

Study Sites (3)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

NOT YET RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Michael Walsh, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Christou, BSc

CONTACT

905-521-2100; courtney.christou@phri.ca

Jessica Tyrwhitt, BSc

CONTACT

jessica.tyrwhitt@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 basket trial including 2 open-label single-arm cohorts: REPAIR CKD cohort and REPAIR Dialysis cohort

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 12, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)